Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE II)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,904
- 主要终点
- Major adverse cardiovascular and cerebrovascular event (MACCE)
研究概览
简要总结
This is a prospective, multi-center, randomized controlled, open-label, blinded endpoint assessment study. The objective is to compare the 1-year incidence of major adverse cardiovascular and cerebrovascular events (MACCE) between two treatment strategies-immediate complete revascularization and staged complete revascularization-in NSTE-ACS patients with multivessel disease (MVD).
NSTE-ACS patients who meet other the inclusion and exclusion criteria will be randomized into the following two groups after signing an informed consent form:
Intervention group Immediate Complete Revascularization: Emergency PCI for the culprit vessel is performed successfully, and simultaneous PCI is conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing).
Control group During emergency intervention, PCI is performed only on the culprit vessel. Elective PCI is then conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥ 2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing)-either during the current emergency hospitalization or within 6 weeks after the culprit vessel PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years or older.
- •Patients with intermediate-to-high risk NSTE-ACS who meet the diagnostic criteria specified in current guideline, complicated by multivessel coronary artery disease, and have successfully undergone PCI for the culprit vessel.
- •PCI within 72 hours of diagnosis.
- •Accompanied by multivessel disease: defined as at least one non-culprit artery that meets the following conditions: a diameter of ≥2.5 mm by visual inspection, which can be successfully subjected to PCI, and the most severe diameter stenosis rate by visual inspection is at least 70% or positive coronary physiology testing.
- •Sign an informed consent form before participating in the study.
排除标准
- •Have received thrombolytic treatment.
- •Cardiogenic shock or SBP< 90 mmHg.
- •Patients in whom the culprit vessel cannot be clearly identified.
- •Left main coronary artery lesion, non-infarct-related arteries are CTO lesions or severely calcified lesions, complex lesions that require the use of special devices such as rotational ablation/laser.
- •Previous PCI within the past 1 month or previous coronary artery bypass graft (CABG).
- •Accompanied by other diseases that lead to an expected survival time of ≤ 12 months.
- •Patients with other serious diseases such as severe renal insufficiency (creatinine clearance value <30ml/min), hepatic insufficiency, thrombocytopenia (≤50*109/L).
- •Patients with severe valvular disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension.
- •Not suitable for clinical study:
- •Have enrolled in the other clinical studies that may affect the outcome assessment of this study.
- •Pregnant and lactating women.
- •Known allergy to the drugs that may be used in the study.
- •Unable to comply with the trial protocol or follow-up requirements; or the investigator believes that participation in the trial may put the patient at greater risk.
研究组 & 干预措施
Immediate Complete Revascularization
干预措施: Immediate Complete Revascularization (Device)
Staged Complete Revascularization
干预措施: Staged Complete Revascularization (Device)
结局指标
主要结局
Major adverse cardiovascular and cerebrovascular event (MACCE)
时间窗: at 1 year after randomization
defined as a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, and stroke
次要结局
- Major adverse cardiovascular and cerebrovascular event (MACCE)(1 month, 6 months, 2 years, 3 years after randomization)
- All-cause death(1 month, 6 months, 1 year, 2 years, 3 years after randomization)
- Cardiac death(1 month, 6 months, 1 year, 2 years, 3 years after randomization)
- Myocardial infarction(1 month, 6 months, 1 year, 2 years, 3 years after randomization)
- Target vessel revascularization(1 month, 6 months, 1 year, 2 years, 3 years after randomization)
- Any coronary revascularization(1 month, 6 months, 1 year, 2 years, 3 years after randomization)
- ARC-2 defined stent thrombosis(1 month, 6 months, 1 year, 2 years, 3 years after randomization)
- Stroke(1 month, 6 months, 1 year, 2 years, 3 years after randomization)
- Contrast agent-related acute kidney injury(1 month after randomization)
- Major bleeding(1 month, 6 months, 1 year, 2 years, 3 years after randomization)